Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.

Therapeutic

No.
The device description and intended use clearly state that these are medical surgical masks intended to protect against transfer of microorganisms and particulate material, which is a barrier function, not a therapeutic one.

Diagnostic

No
The device is a surgical mask intended for protection and infection control, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (mask body, nose piece, ear loops) made of various materials (polypropylene, Melt-blown cloth, iron, nylon, spandex). The performance studies focus on physical properties and biocompatibility, not software functionality.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the masks are for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic one.
Device Description: The description details the physical components of the mask (layers, nose piece, ear loops). There are no components or mechanisms described that would be used to perform a diagnostic test on a sample from the human body.
Performance Studies: The performance studies focus on the physical and biological properties of the mask (fluid resistance, filtration efficiency, biocompatibility, flammability). These are relevant to the mask's function as a barrier, not as a diagnostic tool.
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing information for the diagnosis, monitoring, or treatment of a disease or condition based on in vitro examination of specimens.

In summary, the device is a physical barrier intended for infection control, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The disposable medical surgical masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided as sterile and non-sterile.

Product codes (comma separated list FDA assigned to the subject device)

FXX

Device Description

The surgical mask consists of a mask body, a nose piece, and ear loops. The mask body is divided into three layers, the inner and outer layers are made of polypropylene fabrics; the middle layer is composed of Melt-blown cloth (polypropylene); the nose piece is made of polypropylene & iron (Fe), and the ear loops are made of nylon & spandex.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare personnel

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench testing and Biocompatibility testing were performed. Ethylene oxide Sterilization Validation was also performed for the sterile version.

Bench testing included:

Fluid Resistance Performance
Particulate Filtration Efficiency
Bacterial Filtration Efficiency
Differential Pressure
Flammability

Key results for non-sterile mask:

Fluid Resistance Performance (ASTM F 1862-17): 32 Out of 32 Pass at 160mmHg
Bacterial Filtration Efficiency (ASTM F2101-19): Pass at >= 98% (Lot 1# 99.6%-99.9%; Lot 2# 99.7%-99.9%; Lot 3# 99.6%-99.9%)
Differential Pressure (EN 14683: 2019): Pass at = 98% (Lot 1# 98.0%-98.9%; Lot 2# 98.3%-98.9%; Lot 3# 98.3%-98.9%)
Flammability (16 CFR Part 1610): Class I

Key results for sterile mask:

Fluid Resistance Performance (ASTM F 1862-17): 32 Out of 32 Pass at 160mmHg
Bacterial Filtration Efficiency (ASTM F2101-19): Pass at >=98% (Lot 1# 99.6%-99.9%; Lot 2# 99.6%-99.8%; Lot 3# 99.7%-99.9%)
Differential Pressure (EN 14683: 2019): Pass at = 98% (Lot 1# 98.2%-98.9%; Lot 2# 98.5%-99.1%; Lot 3# 98.6%-99.0%)
Flammability (16 CFR Part 1610): Class I

Biocompatibility testing included:

Cytotoxicity (ISO 10993-5): Non-cytotoxic
Skin Sensitization (ISO 10993-10): Non-sensitizing
Skin Irritation (ISO 10993-10): Non-irritating

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Fluid Resistance Performance: 32 Out of 32 Pass at 160mmHg
Bacterial Filtration Efficiency: Lot 1# 99.6%-99.9%; Lot 2# 99.7%-99.9%; Lot 3# 99.6%-99.9% (non-sterile), Lot 1# 99.6%-99.9%; Lot 2# 99.6%-99.8%; Lot 3# 99.7%-99.9% (sterile)
Particulate Filtration Efficiency Performance: Lot 1# 98.0%-98.9%; Lot 2# 98.3%-98.9%; Lot 3# 98.3%-98.9% (non-sterile), Lot 1# 98.2%-98.9%; Lot 2# 98.5%-99.1%; Lot 3# 98.6%-99.0% (sterile)
Differential Pressure: Lot 1# 4.0-5.2; Lot 2# 4.4-5.4; Lot 3# 3.6-5.2 (non-sterile), Lot 1# 4.0-5.1; Lot 2# 4.1-5.0; Lot 3# 4.3-5.0 (sterile)
Flammability: Class I
Cytotoxicity: Non-cytotoxic
Sensitization: Non-sensitizing
Irritation: Non-irritating

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K160269

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 878.4040 Surgical apparel.

(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 21, 2021

Chongqing COE Display Technology Co., Ltd. % James Tsai Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518000 China

Re: K202759

Trade/Device Name: Disposable medical surgical mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 12, 2020 Received: September 21, 2020

Dear James Tsai:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

1

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For Clarence W. Murray III, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K202759

Device Name Disposable medical surgical mask

Indications for Use (Describe)

The disposable medical surgical masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided as sterile and non-sterile.

Level 3, surgical mask model, sterile: CCSM-SC Level 3, surgical mask model, non-sterile: CCSM-NC

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K202759

1. Administrative Information

Date of Summary prepared	April 17, 2021
Applicant information	Company: Chongqing COE Display Technology Co., Ltd.
	Company address:
No. 3, Tonggui Avenue, Yufengshan Town, Yubei
District, Chongqing, China
	Contact person: Liu Qingjun
	Phone: 86-023-67849398
	Fax: 86-023-67843279
	E-mail: liuqj@szcoe.com
Submission Correspondent	Shenzhen Joyantech Consulting Co., Ltd.
Address: 1713A, 17th Floor, Block A, Zhongguan Times
Square, Nanshan District, Shenzhen
	Contact person: James Tsai
	E-Mail: james_tsai@cefda.com; field@cefda.com

2. Device Information

Type of 510(k) submission:	Traditional
Trade Name:	Disposable medical surgical mask
Classification name:	Surgical Face Mask, Apparel
Review Panel:	General and plastic surgery devices
Product Code:	FXX
Common name	Surgical mask
Device Class:	II
Regulation Number:	878.4040

3. Predicate Device Information

Sponsor:	SAN-M PACKAGE CO., LTD.
Device trade name:	Surgical face mask (Ear loops and Tie-on)
Device Class:	II
510(K) Number:	K160269
Regulation name	Masks, Surgical

4

Production regulation:	21 CFR §878.4040
Product code:	FXX
Review Panel:	General and plastic surgery devices

4. Device Descriptions

The surgical mask consists of a mask body, a nose piece, and ear loops. The mask body is divided into three layers, the inner and outer layers are made of polypropylene fabrics; the middle layer is composed of Melt-blown cloth (polypropylene); the nose piece is made of polypropylene & iron (Fe), and the ear loops are made of nylon & spandex.

5. Indications for Use

The disposable medical surgical masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided as sterile and non-sterile.

6. Summary of Technological Characteristics

Comparison item	Proposed Device	Predicate Device	Remark
Manufacturer	Chongqing COE Display
Technology Co., Ltd.	SAN-M PACKAGE CO.,
LTD.	Different
510k number	K202759	K160269	Different
Product name	Disposable medical surgical
mask	Surgical face mask	Similar
Product model	CCSM-NC	EL 20000	Different
Product Code	FXX	FXX	Same
Classification	Class II (21 CFR 878.4040)	Class II (21 CFR 878.4040)	Same
Intended
use &
Indications for
Use	The disposable medical
surgical masks are intended to
be worn to protect both the
patient and healthcare
personnel from transfer of
microorganisms, body fluids,
and particulate material. These
face masks are intended for
use in infection control
practices to reduce the	The surgical face masks are
intended to be worn to protect
both the patient and healthcare
personnel from transfer of
microorganisms, body fluids,
and particulate material. These
face masks are intended for
use in infection control
practices to reduce the potential exposure to blood	Similar
	potential exposure to blood and body fluids. This is a single-use, disposable device, provided as sterile and non-sterile	and body fluids. This is a single-use, disposable device, provided non-sterile.
Mask features	Ear Loops, flat Pleated	Ear Loops, flat Pleated	Same
Layers	3 layers	4 layers	Different
Outer layer	Polypropylene	Polypropylene	Same
Filter media	Melt-blown cloth
(polypropylene)	Polypropylene spunbond
Polypropylene meltblown	Similar
Inner layer	Polypropylene	Polypropylene	Same
Ear loops	Nylon & Spandex	Ear loops: Polyester, polyurethane	Similar
Nose piece	Polypropylene & Iron (Fe)	Polyethylene coated steel wire	Similar
Color	Blue	White or Blue	Same
Dimension
(Length*Width)	Mask body: 17.5cm*9.5cm
Nosepiece:
length: 8cm-12cm; width: 3cm
Ear loop: 18cm±0.9cm	17.5cm*9.5cm	Same
OTC use	Yes	Yes	Same
Sterility	Non-sterile	Non-sterile	Same
Use	Single-use, disposable	Single-use, disposable	Same
Performance
level	Level 3	Level 3	Same
Fluid Resistance
Performance
ASTM F1862	32 Out of 32 Pass at
160mmHg	32 Out of 32 Pass at
160mmHg	Same
Particulate
Filtration
Efficiency
ASTM F2299	Pass at ≥ 98.0%	Pass at 99.72%	Similar
Bacterial
Filtration
Efficiency
ASTM F2101	Pass at ≥98%	Pass at 99%	Similar
Differential
Pressure
ASTM F2100-19	Pass at 4.6 mm H2O/cm2	Pass at 2.5 mmH2O/cm2	Similar
Cytotoxicity
ISO 10993-5	Under the conditions of the
study, the subject device was
non-cytotoxic	Under the conditions of the
study, the subject device was
non-cytotoxic	Same
Sensitization
ISO 10993-10	Under the conditions of the
study, the subject device was
non-sensitizing	Under the conditions of the
study, the subject device was
non-sensitizing	Same
Irritation
ISO 10993-10	Under the conditions of the
study, the subject device was
non-irritating	Under the conditions of the
study, the subject device was
non-irritating	Same

6.1 Comparisons for non-sterile mask

5

6

The subject device only includes level 3 and ear loops type, it was covered by the scopes of predicate device, which includes level 1, level 2 and level 3, as well as types of ear loop.

Both proposed device and predicate device conform to ASTM F2100, the difference is the versions of the standard, the proposed device was tested by the latest version, and this difference will not raise any new issue of safety and effectiveness of the proposed device.

Although the materials, and layers of subject device are a little different from the predicate device, the performance and biocompatibility testing of the subject device meet all the requirements of standards of ASTM F2100 and ISO 10993-5 &-10. So, the differences between the predicate device and subject device will not raise any new issue of safety and effectiveness of the subject device.

Comparison item	Proposed Device	Predicate Device	Remark
Manufacturer	Chongqing COE Display
Technology Co., Ltd.	SAN-M PACKAGE CO.,
LTD.	Different
510k number	K202759	K160269	Different
Product name	Disposable medical surgical
mask	Surgical face mask	Similar
Product model	CCSM-SC	EL 20000	Different
Product Code	FXX	FXX	Same
Classification	Class II (21 CFR 878.4040)	Class II (21 CFR 878.4040)	Same
Intended
use &
Indications for
Use	The disposable medical
surgical masks are intended to
be worn to protect both the
patient and healthcare
personnel from transfer of
microorganisms, body fluids,
and particulate material. These
face masks are intended for
use in infection control	The surgical face masks are
intended to be worn to protect
both the patient and healthcare
personnel from transfer of
microorganisms, body fluids,
and particulate material. These
face masks are intended for
use in infection control
practices to reduce the	Similar
	practices to reduce the
potential exposure to blood
and body fluids. This is a
single-use, disposable device,
provided as sterile and non-sterile	potential exposure to blood
and body fluids. This is a
single-use, disposable device,
provided non-sterile.
Mask features	Ear Loops, flat Pleated	Ear Loops, flat Pleated	Same
Layers	3 layers	4 layers	Different
Outer layer	Polypropylene	Polypropylene	Same
Filter media	Melt-blown cloth
(polypropylene)	Polypropylene spunbond
Polypropylene meltblown	Similar
Inner layer	Polypropylene	Polypropylene	Same
Ear loops	Nylon & Spandex	Ear loops: Polyester,
polyurethane	Similar
Nose piece	Polypropylene & Iron (Fe)	Polyethylene coated
steel wire	Similar
Color	Blue	White or Blue	Same
Dimension
(Length*Width)	Mask body: 17.5cm*9.5cm
Nosepiece:
length: 8cm-12cm; width: 3cm
Ear loop: 18cm±0.9cm	17.5cm*9.5cm	Same
OTC use	Yes	Yes	Same
Sterility	Sterile	Non-sterile	Different
Packaging
material	Paper plastic bag	Not publicly available	Different
Sterilization
method and
S.A.L.	Sterilized by ethylene
oxide gas, SAL=10-6	Not applied	Different
Residues	MEO≤4mg/d; MECH≤9mg/d	Not applied	Different
Shelf life	No shelf life claim	No shelf life claim	Same
Use	Single-use, disposable	Single-use, disposable	Same
Performance
level	Level 3	Level 3	Same
Fluid Resistance
Performance
ASTM F1862	32 Out of 32 Pass at
160mmHg	32 Out of 32 Pass at
160mmHg	Same
Particulate
Filtration
Efficiency
ASTM F2299	Pass at ≥ 98.0%	Pass at 99.72%	Similar
Bacterial
Filtration
Efficiency
ASTM F2101	Pass at ≥98%	Pass at 99%	Similar
Differential
Pressure
ASTM F2100-19	Pass at 4.8 mm H2O/cm²	Pass at 2.5 mmH2O/cm2	Similar
Flammability 16
CFR 1610	Class I	Class I	Same
Cytotoxicity
ISO 10993-5	Under the conditions of the
study, the subject device was
non-cytotoxic	Under the conditions of the
study, the subject device was
non-cytotoxic	Same
Sensitization
ISO 10993-10	Under the conditions of the
study, the subject device was
non-sensitizing	Under the conditions of the
study, the subject device was
non-sensitizing	Same
Irritation
ISO 10993-10	Under the conditions of the
study, the subject device was
non-irritating	Under the conditions of the
study, the subject device was
non-irritating	Same

6.2 Comparisons for sterile mask

7

8

The subject device only includes level 3 and ear loops type, it was covered by the scopes of predicate device, which includes level 1, level 2 and level 3, as well as types of ear loop.

Both proposed device and predicate device conform to ASTM F2100, the difference is the versions of the standard, the proposed device was tested by the latest version, and this difference will not raise any new safety and effectiveness of the proposed device.

Although the materials, layers and sterility status of subject device are a little different from the predicate device, the performance, biocompatibility and EO sterilization of the subject device meet all the requirements of standards of ASTM F2100, ISO 10993-5 &-10 and ISO 11135. So. the differences between the predicate device and subject device will not raise any new issue of safety and effectiveness of the subject device.

7. Brief discussion of Non-Clinical Testing

Surgical Face Mask conforms to the following standards:

ASTM F 2100-19, Standard Specification for Performance of Materials Use in Medical Face Masks.

ISO 10993-1:2018, Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process.

Bench testing

The bench testing of Surgical Face Mask includes the following tests: *Fluid Resistance Performance *Particulate Filtration Efficiency *Bacterial Filtration Efficiency

*Differential Pressure

9

*Flammability

Biocompatibilitv testing

The biocompatibility evaluation for the proposed device was conducted in accordance with the International Standard ISO 10993-1: 2018 "Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA. Biocompatibility evaluation included the following tests:

· Cytotoxicity
· Skin Sensitization
· Skin Irritation

Ethylene oxide Sterilization Validation

The proposed device is also provided for sterilization validation is performed, and the results show that the proposed device complies with the following standards:

· ISO 11135:2014 Sterilization of health-care products Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
ISO 11737-1:2018 Sterilization of health care products Microbiological methods - Part 1: Determination of a population of microorganisms on product
· ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
ASTM F88-2015 Standard Test Method for Seal Strength of Flexible Barrier Materials
· ASTM F1929-2015 Standard test method for detecting seal leaks in porous medical packaging by dye penetration.

Summarv

Based on the non-clinical performance data as documented above in the device development, the proposed device has a safety and effectiveness profile that is similar to the predicate device, the testing results are summarized in the following table:

| Name of Test
Methodology
(standard) | Purpose | Acceptance
Criteria | Results | |
|-------------------------------------------|---------------------------------------|-------------------------------------|---------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| ASTM F 1862-
17 | Fluid
Resistance
Performance | 29 out of 32
pass at
160 mmHg | Lot 1# pass at
160mmHg;
Lot 2# pass at
160mmHg;
Lot 3# pass at
160mmHg | Lot 1# pass at
160mmHg;
Lot 2# pass at
160mmHg;
Lot 3# pass at
160mmHg; |
| ASTM F2101-
19 | Bacterial
Filtration
Efficiency | $\ge$ 98% | Lot 1# 99.6%-99.9%;
Lot 2# 99.7%-99.9%;
Lot 3# 99.6%-99.9% | Lot 1# 99.6%-99.9%;
Lot 2# 99.6%-99.8%;
Lot 3# 99.7%-99.9% |

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	Performance
EN 14683:
2019	Differential
Pressure
(Delta-P)